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Emicizumab Calibrator and Controls

Emicizumab Calibrator is a calibrator intended for use in the calibration of a modified one-stage FVIII activity assay for the determination of active emicizumab concentration from a clot time measurement performed on an automated coagulation analyzer.

Emicizumab Calibrator may be used together with a modified one-stage FVIII assay to generate a calibration curve for emicizumab determination using citrated plasma from patients with haemophilia A being treated with the drug.

Emicizumab Controls Level 1 and Level 2 are assayed controls intended for quality control of a modified one-stage FVIII activity assay for determination of active emicizumab concentration from a clot time measurement performed on an automated coagulation analyzer.

Emicizumab Controls may be used together with Emicizumab Calibrator and a modified one-stage FVIII assay as QC material for use in a laboratory's quality control program.